It is no surprise to any ophthalmologist that today's patients have high expectations. They have done their research, they know what they want, and they are reluctant to settle for anything less than perfection. If a complication arises, patients demand a timely resolution.
This was made clear recently, when the US Food and Drug Administration (FDA) responded to 140 letters of complaint regarding the safety of the LASIK procedure. On April 25, the FDA Ophthalmic Devices Panel conducted a hearing on post-LASIK quality-of-life issues and concluded that questionable clinical practices, and not the safety of the devices, may be responsbile for the public's concern.
"All people undergoing laser refractive surgery deserve the best quality of surgical practice—wherever that practice is delivered, be it premium refractive practices or LASIK chains," said Brenda Billington, MB, FRCS, FRCOphth, President of the Royal College of Ophthalmologists (RCOphth), in an e-mail to CRST Europe.
According to the RCOphth, all ophthalmologists practicing refractive surgery should consider upholding a set of laser refractive standards. At a time when the public seems to be calling the practice of refractive surgery into question, adhering to such standards may ensure a greater degree of safety and patient satisfaction.
"The Royal College of Ophthalmologists promotes excellence in the practice of ophthalmology," Miss Billington said. "To this end, we publish evidence-based guidelines and set standards to cover certain areas of clinical practice, including laser refractive surgery."
First published in December 2003 and revised the following year, the RCOphth Standards for Laser Refractive Surgery are "intended to advise and assist ophthalmologists who perform laser refractive surgery," according to the opening paragraph of the standards.1
The document includes seven sections, covering (1) surgeons carrying out refractive procedures, (2) facilities, (3) information for patients, (4) the consent process, (5) clinical governance, (6) advertising and marketing, and (7) postoperative evaluation.
SURGEONS CARRYING OUT REFRACTIVE PROCEDURES
In addition to registering with the General Medical Council, all ophthalmologists should have a broad knowledge of ophthalmology and undergo specific refractive surgical training. Additionally, surgeons should "recognize and work within the limits of their professional competence," according to language in the RCOphth standards.
The standards suggest retaining a folder that includes documentation of ongoing education in the practice and techniques of refractive surgery. The folder should also contain any audits of refractive surgery procedures, therefore ensuring that the surgeon's knowledge and skills in the field of refractive surgery are current. Surgeons are also urged to maintain membership in relevant professional organizations that provide "continuing professional development and adhere to the principles of good medical practice," according to the standards.
FACILITIES
Registering the surgical facility under the appropriate Healthcare Standards Commission and properly maintaining and calibrating equipment are highlighted in this section of the RCOphth's standards for laser refractive surgery. Dated and documented procedures for clinical equipment must be reviewed annually, and all staff members must be trained in how to properly use the equipment. Areas in the clinic designated for confidential surgeon-patient discussions should have visual and auditory privacy.
INFORMATION FOR PATIENTS
The RCOphth recommends having the following published information, written in concise, nontechnical language, available to patients: range of refractive procedures, including those available within the practice in question; eligibility criteria; treatment options, including advantages and disadvantages of each; general and specific risks and complications, including frequency, management, and possible outcomes; and statistical information, including the chance of achieving the desired outcome, retreatment, or needing more than one procedure. Patients should also be made aware of the price associated with each procedure and how payments are processed, including deposits, refunds, and any penalties incurred by cancellation.
Additionally, patients should always be informed of the operating surgeon's qualifications and substantive posts held within the past 10 years. Information regarding how to file a complaint or make a suggestion should be visible within the facility.
Patients should also undergo and receive a copy of results for preoperative keratometry and pachymetry and pre- and postoperative BCVA, intraocular pressure, and refraction. If the patient is scheduled for bilateral same-day surgery, the risks and preventive measures should be described. For example, cross-contamination, can be avoided by treating each eye as an individual procedure (ie, using different equipment in each eye).
After the procedure is complete, the patient should receive written postoperative instructions and a contact phone number in the case of emergency.
CONSENT PROCESS
Guidelines set forth by the General Medical Council and Department of Health are a major part of the RCOphth's consent process. Patients must attend an appointment with the operating surgeon prior to the day of surgery.
The surgeon must provide an informational document at least 24 hours before surgery so that the patient may review it and discuss the risks and benefits. After recapping the treatment, expectations, potential risks, and alternative treatments during the preoperative assessment, the patient should be asked if he has any questions and fully understands the written and discussed material.
A signed consent form must also be obtained, including the elective nature of the procedures, the potential for glasses or contact lenses to still be required after surgery, the potential for pain or discomfort, and any material risks pertaining to the individual patient in question. Within a section on the form, the surgeon should certify (in his professional opinion) that the patient has fully understood the risks, benefits, alternative treatments, and potential complications associated with the procedure.
CLINICAL GOVERNANCE
The No. 1 item in this section of the RCOphth's standards for laser refractive surgery reads, "surgeons must be personally responsible for patient care," including the maintenance of outpatient services to assess patient selection and provision of follow-up care. The clinical staff at any given practice should have documented, ongoing refractive surgery education.
The practice should also have a clinical audit program in place, in which surgeons' quality indicators are reviewed on regular intervals. If an adverse report is generated, it should be reported to the medical advisory committee. If errors or "near misses" occur, they must be recorded, investigated, collated, and discussed regularly with the medical advisory committee or an equivalent management group, according to the standards.
Additional clinical governance guidelines include maintaining integrated care pathways/clinical guidelines and creating entries into the care pathway notes for each patient, as well as training clinical support staff, such as optometrists or registered nurses who may carry out procedures on the surgeon's behalf, to be competent in the techniques.
ADVERTISING AND MARKETING
All advertising must be legal, factual, not misleading, and must adhere to the standards of the Advertising Standards Authority, according to the RCOphth's standards of refractive surgery. Additionally, advertising should follow the British Medical Association and General Medical Council standards when applicable. If attending a promotional event, staff and speakers should clearly identify their profession and role in their organization.
POSTOP EVALUATION
The RCOphth's standards state that, "a refractive surgeon should examine … the patient at the first postoperative visit" and that it is his responsibility to "ensure that the postoperative management is carried out appropriately," which is in accordance with the General Medical Council's text, Good Medical Practice.2 Furthermore, it is expected that all refractive surgeons are fully trained to treat complications associated with refractive surgery. Lastly, the refractive surgeon should inform the patient's general practitioner about any procedures or treatments performed.
"These [laser refractive surgery] standards should be identical in premium centers and LASIK chains," Larry Benjamin, DO, FRCS, FRCOphth, said in an E-mail to CRST Europe. "It is hoped that surgeons practicing laser refractive surgery will be aided by these guidelines and that they will give insight as to the standards required for this and other forms of surgical practice."
ENDORSED BY SEVERAL ORGANIZATIONS
The European Society of Cataract and Refractive Surgeons (ESCRS), United Kingdom and Ireland Society of Cataract and Refractive Surgeons (UKISCRS), Medical Contact Lens and Ocular Surface Association (MCLOSA), College of Optometrists (CoO), and Association of Optometrists (AOP) endorse the RCOphth's standards for laser refractive surgery. For a complete listing of the standards, visit www.RCOphthphth.ac.uk/about/public/laser.
The RCOphth have also introduced a laser refractive surgery assessment that provides a certificate of competence to practice upon completion. Surgeons who undergo assessment will be subject to yearly appraisals and continuing professional development.
Larry Benjamin, DO, FRCS, FRCOphth, is in the Department of Ophthalmology at Stoke Mandeville Hospital, Aylesbury, UK. He is a member of the CRST Europe Editorial Board. Dr. Benjamin may be reached at E-mail: larry.benjamin@btopenworld.com.
Brenda Billington, MB, FRCS, FRCOphth, is the President of the Royal College of Ophthalmologists. Miss Billington may be reached at E-mail: President@RCOphthphth.ac.uk.
